Dietary Supplements: Labels and Contents for Dietary Supplements

Although it does not regulate supplements, the U.S. Food and Drug Administration (FDA) requires manufacturers of dietary supplements to follow certain guidelines when describing their products.

A supplement label must include the following statement:

This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

The manufacturer must notify the FDA within 30 days after a product is on the market if it bears such a label.

The FDA also bans manufacturer claims that a supplement can treat a disease. In other words, claims made by a manufacturer that a buyer could misconstrue as indicating treatment or prevention of a disease are no longer allowed.

In new regulations, a product may make health maintenance claims but not disease claims. For example, “maintains a healthy prostate” is allowed, but “treats benign prostatic hyperplasia” is not.

Look for These Label Details

The FDA requires that supplement labels contain certain information, so look for these details when you shop for products.

  • Name of the product
  • Name and address of the manufacturer
  • Complete list of ingredients, including a “Supplement Facts” panel, which identifies each ingredient in the product. If an ingredient is not listed on the “Supplement Facts” panel, it must be listed in the “other ingredient” statement below the panel.
  • Directions for use
  • Net quantity of the contents

Confusion Persists

Despite these requirements, the labels of dietary supplements can be confusing and misleading.

A study of more than 800 bottles of popular herbs sold in retail stores found that over half the products were inconsistent in reporting benchmark ingredients and recommended daily doses.

In addition, the actual contents of products may not be reflected in the packaging.

A study of the popular botanical Echinacea, found numerous discrepancies in the ingredients listed on products. Ten percent of the products tested contained no measurable Echinacea.

Next: Independent Testing Organizations

This material is adapted from The American Diabetes Association Guide to Herbs & Nutritional Supplements, written by Laura Shane-McWhorter, PharmD, BCPS, FASCP, BC-ADM, CDE, and published by the American Diabetes Association, ©2009.

  • Last Reviewed: February 20, 2014
  • Last Edited: May 14, 2014

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